Batch Records

1
Welcome
2
Batch Records

• One
• Big
• Recipe

Bobbi Jo, Dainna, Kola, Brenda Piao Piao
3
Introduction

• What Is a Batch Record?
• Who Uses Batch Records?

4
Introduction

• It is essential that the Batch Record issued is
  complete, readable, and correct.

5
Essential Components of aBatch Record

• Product Identification
• Document Identification
• Company Name
• Dates of Manufacturing
• A step by step account of the processing and
  testing to be done

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Components of a Batch Record

• The monitoring specifications-how will the
  operators know if the process is proceeding
  properly
• Raw data must be collected and blanks must be
  filled in with the information
• Materials and equipment used must be recorded
• Signatures required

7
Laboratory Notebooks

• Laboratory Notebooks
• A Chronological Log
• Complete and Accurate
• Raw Data
• Components

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Standard Operating Procedures
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Standard Operating Procedures

• Definition
• Components
• Title
• Identification
• Purpose
• Scope
• Responsibility
• Materials

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S.O.P. (cont)

• Calculations
• Procedure
• References
• Documentation
• Problems Related to S.O.Ps

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Absolutely Sinful Chocolate Chocolate Chip
Cookies

• Yields 2 dozen.
• Prep Time15 Minutes
• Cook Time12 Minutes
• Ready In40 Minutes

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Ingredients

• 70 g unsweetened chocolate
• 115 g butter
• 250 g all-purpose flour
• 2 g baking soda
• 3 g baking powder

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Ingredients (cont)

• 2 g salt
• 250 g white sugar
• 2 eggs
• 5 ml vanilla extract
• 155 g sour cream
• 335 g semisweet chocolate chips

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Directions

• Preheat oven to 375 degrees F (190 degrees C).
• In the microwave or over a double boiler, melt
  unsweetened chocolate and butter together,
  stirring occasionally until smooth.
• Sift together flour, baking soda, baking powder,
  and salt set aside.

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• Directions
• In a medium bowl, beat sugar, eggs, and vanilla
  until light.
• Mix in the chocolate mixture until well blended.
• Stir in the sifted ingredients alternately with
  sour cream, then mix in chocolate chips.
• Drop by rounded tablespoonfuls onto ungreased
  cookie sheets.

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KB2 Delightful Pleasures

• Product I.D. Absolutely Sinful
• Chocolate Chocolate Chip Cookies
• Product Batch Number ASC-1
• Date of Manufacturing
• Monday February 9, 2004

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Checklist for Standard Operating Procedure
(I.D. KDB-1)

• __ Weighed all dry materials
• __ Measured all liquids
• __ Acquired all other ingredients which do not
  require measurements (eg, Eggs)
• __ Acquired all necessary utensils (spoons)
• __ Acquired all necessary glassware (bowls) and
  bake ware (cookie sheets)
• __ Acquired all necessary appliances

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Equipment Manual for the Stove (another S.O.P)
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Equipment Manual for the Stove(aka S.O.P.)

• Adjust the baking rack to the center of the oven
• Select the bottom element of the oven by rotating
  the knob to the appropriate setting on the stove.
• Adjust the temperature knob to 1900 C
• Bake for 8-10 minutes in preheated oven

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Checklist for Preheating the Oven(I.D. KDB-2)

• __ Adjust baking rack to the center
• of the oven
• __ Select the bottom element of the
• oven using the appropriate knob
• __ Adjust temperature knob to 1900 C
• __ Bake 8-10 min. in preheated oven

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Holding, Cooling, and StorageProtocols

• Remove cookie sheets from oven using hot mitts
• Allow cookies to cool on a baking sheet for a
  minimum of 5 minutes
• Transfer all cookies from baking pans to wire
  racks until completely cooled
• Store cookies in an airtight container

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Checklist for Holding, Cooling, and Storage
(I.D. KDB-3)

• __ Cookie sheets removed from oven
• __ 5 minutes allotted for cooling cookies on
  the cookie sheets
• __ Cookies transferred to wire racks
• __ Cookies completely cooled
• __ Cookies placed in air tight container for
  storage

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Flow Chart for Batch Records
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Forms

• Purpose
• Procedure
• Data to be included
• Name/Date
• Lot/Sources
• Masses
• Sources
• Times/Temperatures

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Protocols

• Definition
• Purpose
• Components
• Objectives
• Plan
• Equipment
• Procedure

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Reports

• Definition/Purpose
• Outcomes

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Logbooks

• Purpose

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Recordings from Instruments

• Printouts
• Procedure/Protocol
• Identification

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Other Types of Documentation Included in Batch
Records

• Electronic Documentation
• Analytical Laboratory Documents
• Identification Numbers
• Labels
• Chain of Custody Documentation

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Conclusion

• Batch records are a combination of any of the
  different types of documentation.
• They accompany the batch of product through all
  phases of manufacturing
• If any information is missing or not accounted
  for the batch will be no good

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Certificate of Analysisfor KB2 Delightful
Pleasures

• Cookies are
• __ Great __ Awful
• __ Chewy __ Too Chewy
• __ Crunchy __ Too Crunchy
• __ Chocolaty __ Too Sweet
• __ Minty __ Too Salt
• __ Delicious __ Too Soft

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Thank You

• Presented by
• Brenda, Bobbi-Jo, Dainna,
• Kola and Piao Piao